Scottish Medicines Consortium April 2015 decisions

Treatments for leukaemia, lung cancer and multiple sclerosis among seven new medicines accepted by SMC.

This month’s advice from the Scottish Medicines Consortium (SMC) features seven new medicines that have been accepted for use in NHS Scotland.

Three of these medicines, ponatinib (Iclusig) for chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute leukaemia (Ph+ALL), regorafenib (Stivarga) for gastrointestinal stromal tumours (GIST – a cancer of the digestive system) and nintedanib (Vargatef) for lung cancer, were considered using SMC’s PACE (Patient and Clinician Engagement) process, which aims to improve access to new medicines for the treatment of end of life and very rare conditions.

Ponatinib is used to treat CML and Ph+ALL which are rare and aggressive forms of leukaemia. Ponatinib offers extended survival and better symptom control for patients who cannot tolerate other treatment options leading to significantly improved quality of life. It can also be used to treat patients with a rare genetic mutation (T3151) for whom there is no current treatment.

Regorafenib is for the treatment of adult patients with GIST which cannot be removed surgically or has spread to other parts of the body. Regorafenib was considered under the SMC’s decision making process for very rare (ultra-orphan) and end of life conditions. This process allows the Committee to consider the wider impact a medicine may have for patients and their carers beyond direct health benefits and also its impact on specialist services and costs to the NHS and Personal Social Services. Through the PACE process, patient groups stated that regorafenib offered hope to patients with advanced GIST who are intolerant to other current treatments, to whom no other treatment option is available and who generally have a life expectancy of less than 12 months.

Nintedanib, which was also considered under the PACE process, is used in combination with another medicine, docetaxel, to treat adult patients with a particular type of non-small cell lung cancer (NSCLC of adenocarcinoma tumour histology) who have already had chemotherapy. During the PACE process patients and clinicians highlighted that the increase in life expectancy and improvements in quality of life which nintedanib may offer patients was significant in the context of their limited remaining months.

The Committee also accepted fingolimod (Gilenya) for use in adult patients with highly active relapsing remitting multiple sclerosis (RRMS) despite previous treatment with at least one disease modifying therapy (not only beta-interferon) . SMC has previously accepted fingolimod for use in patients with a high disease activity in this type of MS despite treatment with the disease modifying therapy beta-interferon.

Sucroferric oxyhydroxide (Velphoro) was accepted for the control of phosphorus levels in patients with adult chronic kidney disease (CKD) who are on haemodialysis (HD) or peritoneal dialysis (PD). Patients with this condition have to limit their daily fluid allowance and can experience difficulties swallowing the large tablets which are part of other current treatments. Sucroferric oxyhydroxide is a chewable tablet which does not require any extra fluid to be taken, giving patients a further option which can help them keep to their medication regime.

Aclidinium/formoterol fumarate dihydrate (Duaklir Genuair) is a combination inhaler that was accepted for the relief of symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD covers several conditions, including long term bronchitis and emphysema, in which the airways or the lungs are blocked or narrowed, usually due to inflammation of the airways.

Aclidinium/formoterol combines two different medicines that open the airways in one inhaler making it easier for patients to manage their condition.

Also accepted was levonorgestrel (Jaydess), an intrauterine device which provides contraception for up to three years.

Professor Jonathan Fox, chairman of the SMC, said:

“We are pleased to be able to accept these new medicines, which include three medicines considered under the new PACE (Patient and Clinician Engagement) process for medicines used for end of life or very rare conditions, with one being an ‘ultra-orphan’ medicine for an extremely rare condition. This brings the number of medicines accepted under PACE to 13, with five not recommended.

“SMC worked closely with patient groups and clinicians to develop PACE and their input to the process has been valuable in helping the Committee reach its decisions. Thanks to their willingness to work with us on PACE and participate in meetings, and the Committee’s commitment to our new processes, patients are beginning to see the benefits of increased access to effective new medicines.”

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